Presbyopic Wear Experience With Multifocal Lenses Compared to Single Vision Lenses and Reading Glasses

NCT07218731 | Recruiting FDA Device

• 1 other identifier: STUDY20252007
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to assess participant experience when wearing multifocal contact lenses compared to spherical contact lenses with reading glasses.

Conditions

Presbyopia Correction; Presbyopia

Outcome Measures

Primary Outcomes (1)

• Preference Survey

  Percentage of participants who prefer the multifocal lenses compared to spherical lenses with reading glasses.

  8 weeks

Study Arms (2)

Multifocal contact lenses

ACTIVE COMPARATOR

multifocal contact lenses

Device: Multifocal contact lenses

Spherical contact lenses with reading glasses

ACTIVE COMPARATOR

spherical contact lenses used with reading glasses

Device: Spherical contact lenses

Interventions

Multifocal contact lenses DEVICE

Multifocal contact lenses

Multifocal contact lenses

Spherical contact lenses DEVICE

spherical contact lenses

Spherical contact lenses with reading glasses

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 40 years of age.
• Ability to give informed consent.
• Subjects must have corrected distance visual acuity in both eyes equivalent to 20/25 or better at the screening visit.
• Require an add power of +0.75 D or greater when tested at 40cm.
• Good general health defined by medication use that has not changed within the last 30 days and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the Investigator.

You may not qualify if:

• Current or active inflammation or infection as determined by the Investigator.
• Current eye disease, infection or inflammation that affects the surface of the eye such as but not limited to moderate or greater blepharitis and ocular allergy.
• History of refractive surgery.
• Known history of allergy or sensitivity to contact lens solutions and/or sodium fluorescein.
• Is pregnant or lactating or planning a pregnancy during enrollment of the study.
• Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable.
• Have been diagnosed with dry eye previously
• Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University College of Optometry

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Study Coordinators

CONTACT

614-292-8858; OPT-EyeStudies@osu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 15, 2025
• First Posted: October 20, 2025
• Study Start: December 8, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)